SC Attorney General reaches $26M settlement against AstraZeneca

Published: Thursday, August 23, 2012 at 5:46 p.m.

Last Modified: Thursday, August 23, 2012 at 5:46 p.m.

The S.C. Attorney General's Office has secured a $26 million settlement against the multi-billion pharmaceutical company AstraZeneca for violating the state Unfair Trade Practices Act by willfully misleading consumers on the potentially serious side effects of the anti-psychotic drug Seroquel.

The settlement order was filed Aug. 22 and is the third award, and final case against anti-psychotic drug manufacturers in South Carolina, that the Attorney General's Office has prosecuted since 2009. The cases began under former Attorney General Henry McMaster, who contracted with the Spartanburg law firm of Harrison, White, Smith and Coggins to prosecute the case on behalf of the state. The Spartanburg firm then contracted with two other firms in Columbia and Houston to assist with the litigation, which continued under Attorney General Alan Wilson.

In the lawsuit order, the company agreed to pay $26 million, which includes $20 million in damages and restitution to the state, $5 million in penalties and $1 million in trial costs. In 2010, AstraZeneca had $5.3 billion in worldwide sales including $3.75 billion in the U.S.

Bryan Stirling, deputy attorney general, said the settlement is fair to the state. A portion of the funds will go into the general fund, some will go to Medicaid and other funds to insurance companies.

Stirling said the Attorney General's Office sued on behalf of the state and the state agencies that paid additional funds because of the medication side effects.

AstraZeneca did not admit any wrongdoing or violation, but agreed to pay the sum to resolve the state action, according to the order signed by Circuit Court Judge Roger Couch."

Thursday, June 14, 2012

DoD cracks down on off-label drug use

A letter landed in Stan White’s mailbox in Cross Lanes, W.Va., in April.
It began: “On behalf of the men and women of the U.S. Armed Forces … I extend my sincerest and deepest sympathy for the loss of your sons.”

But the note wasn’t simply a condolence. The message from Air Force Lt. Gen. Brooks Bash informed White that U.S. Central Command had decided in March to remove the powerful antipsychotic drug Seroquel from its approved formulary list.

Under the new rules, CENTCOM doctors now must request a waiver if they write a prescription for Seroquel, also known as quetiapine.

The change is a small victory for White, who had already lost one son to combat and has sought restrictions on the drug he believes contributed to the death of a younger son.

Marine Cpl. Andrew White died Feb. 12, 2008, at age 23 from a lethal combination of medications prescribed for post-traumatic stress disorder, mainly clonazepam, quetiapine and paroxetine — the latter two known to sometimes affect the heart’s regular rhythm.

“I have never been one to say I’m opposed to medication — I’m just opposed to these medications, which have a side effect of causing cardiac arrest,” White said June 6.

Off-label use soars

Prescriptions for Seroquel have exploded in the past decade, especially in the armed forces, where it often is prescribed off-label as a sleep aid.

In 2003, service members were diagnosed with insomnia at a rate of 30 per 10,000; by 2009, the rate had risen to 226 per 10,000. Prescriptions for Seroquel, or quetiapine, have subsequently soared, multiplying 27-fold in the same time period.

The drug is known to cause drowsiness and chase away nightmares associated with post-traumatic stress disorder.

Navy Capt. Mike Colston of the Office of the Assistant Secretary of Defense for Health Affairs said medications become popular as providers learn about them and as they receive new approvals for use by the Food and Drug Administration — in the case of quetiapine, as an add-on therapy for antidepressants.
Yet questions have been raised over whether its off-label use for insomnia was more than a grass-roots movement by physicians. In April 2010, manufacturer Astra-Zeneca agreed to pay $520 million to the federal government to settle a civil suit alleging that it illegally marketed Seroquel for a host of off-label uses such as Alzheimer’s disease, anxiety, PTSD and sleeplessness.

According to The Associated Press, in 2009, the Pentagon spent $8.6 million on the drug, while the Veterans Affairs Department spent $125.4 million.

Recent moves by the Pentagon to restrict prescriptions for atypical antipsychotic drugs were the result of a search for safe, proven therapies for troops, Colston said.

“We aim to … discourage the use of off-label medication treatments with antipsychotic medications before established evidence-based strategies have been implemented,” he said.

Earlier this year, Assistant Secretary of Defense for Health Affairs Dr. Jonathan Woodson asked the military services to monitor prescriptions for atypical antipsychotic medications, a class of drugs that includes quetiapine.
The medications are approved by the Food and Drug Administration for treating schizophrenia and bipolar disorder. But in the past decade, their popularity has soared for off-label use, including for treating PTSD and insomnia.

A 2011 study of 692 patients prescribed quetiapine at Madigan Army Medical Center, Wash., showed just 9.4 percent received it for an FDA-approved use, while 57 percent received it for insomnia.
In 2011, the services issued 54,581 prescriptions for Seroquel alone, the most for any antipsychotic medication — more than 2.5 times the number of prescriptions for the second-most prescribed atypical antipsychotic, Abilify, and nearly four times the number for risperidone, according to information obtained by a Military Times under a Freedom of Information Act request.

A growing alarm

Quetiapine has the strongest somnolent effect of all atypical antipsychotics, and is commonly prescribed troops for relieving nightmares.

But as its popularity has grown, evidence has mounted pointing to links between atypical antipsychotics and irregular heartbeat and even death — prompting critics and physicians, including Woodson, to sound the alarm on frequent prescriptions.

“Providers should use caution when these agents are used as sleep aids in service members struggling with substance use disorders, especially given the risk of such side effects as glucose dysregulation and cardiac effects,” Woodson wrote Feb. 22.

A study in the January 2009 New England Journal of Medicine found the rate of sudden cardiac death doubled for those taking atypical antipsychotic drugs, and there were three such deaths per year for every 1,000 patients taking the medication.

The risk of a fatal heart event also increased with dosage, and study author and Vanderbilt University researcher Wayne Ray said mixing these medications with others that cause irregular heartbeat, known medically as QT prolongation, could worsen the issue and possibly cause death.

“We saw this strong relationship between the antipsychotics and sudden death … and all the information we had pointed to the drugs as the cause,” Ray said after the study was published. “Our findings … would suggest avoiding other medications that prolong QT whenever possible because when you give two together, you’re … increasing the patient’s risk.”

The Madigan study, conducted by Army Lt. Col. Vincent Mysliwiec and presented last June at a meeting of the American Academy of Sleep Medicine, showed that of 692 patients who took quetiapine, 126 were monitored for heart arrhythmia within six months of starting on the drug, and of those, 11 showed an abnormal heart rhythm.

Ten of those cases were directly attributed to quetiapine; when the medication was stopped, their heart rhythm returned to normal, according to Psychiatric News.

Through an Army spokesman, Mysliwiec declined to release the study but said it was available to Defense Department physicians on request.

A 2008 Dutch study also showed patients taking more than one QT-interval-prolonging drug had 4.8 times the risk of cardiac arrest.

‘He just died’

White attributes his son’s death, and those of at least three others from West Virginia — Army Pfc. Derick Johnson, 22; Army National Guard Sgt. Eric Layne, 29; and Marine Cpl. Nicholas Endicott, 24 — to at least two heart-rhythm-altering drugs, quetiapine and paroxetine.

Since their cases were publicized, others have stepped forward, including Alicia McElroy, whose husband, Army National Guard Staff Sgt. James McElroy, 30, was found dead in his barracks while receiving treatment for PTSD at Fort Benning, Ga.

She said that among his many medications were Paxil, Seroquel and Klonopin.
“This wasn’t a long, slow death. It wasn’t an overdose. He wasn’t found unconscious. He just died,” said Alicia McElroy, who is still awaiting autopsy results. Her husband died June 6, 2011.

Seroquel maker AstraZeneca stands behind the safety record of its medication, which it made exclusively until March 2012, when the patent expired.

“Patient safety is a priority for AstraZeneca, and we think Seroquel is safe and effective when it’s used as recommended,” Stephanie Andrzejewski said.

She added the company does not condone prescribing Seroquel for off-label uses.
“We trust doctors to use medical judgment in … determining when it is appropriate to prescribe medications,” she said.

In July 2011, the FDA required AstraZeneca to add a warning to the drug’s label regarding its potential cardiac risk.

The services take action

The service surgeons general have responded to Woodson’s request for their policy guidance on atypical antipsychotics, Defense Department spokesman Navy Capt. Michael Colston said June 4. According to documents released by Colston:

• The Army decided risperidone should not be prescribed because its risks outweigh its benefits, and providers who prescribe other such drugs, including quetiapine, “must clearly document their rationale” and receive informed consent from the patient.

• The Navy Department agreed to monitor providers and flag those who prescribe the most atypical antipsychotics off-label for additional review.

• The Air Force, which prescribes atypical antipsychotics to “fewer than 0.15 percent of airmen,” will review provider prescribing practices and counsel those who show a pattern.

• The Washington, D.C., area medical command will conduct periodic evaluations of drugs prescribed to patients with PTSD and follow-up evaluations to see whether further monitoring is needed.

White, who had another son, Army Sgt. Robert White, killed in combat, said he is glad the military is moving away from medications for PTSD.

“I know people who have died from medication,” he said. “I don’t know anyone who’s ever been killed by counseling.”

By Ed Silverman // June 14th, 2012
But growing concern over links between antipsychotics – especially Seroquel, which is the most widely prescribed antipscyhotic by the US military – and irregular heartbeats is prompting moves to restrict usage. For instance, a retrospective review of 692 patients who were prescribed Seroquel at the Madigan Army Medical Center in 2007 and 2008 found that only 3.4 percent received the drug for an approved use, which would also include adjunct treatment for depression.

However, 60 percent received the drug for insomnia, 19 percent for anxiety, 12 percent for mood disorders and 8 percent for post-traumatic stress disorder. Yet, only 18 percent were screened for irregular heartbeats and 126 underwent an EKG, with 11 percent showing abnormal heart rhythms, according to a presentation at the American Academy of Sleep Medicine annual meeting (here is the presentation – see page A179).

Such findings underscore the concerns. Last year, the armed services issued 54,581 prescriptions for Seroquel alone, the most for any antipsychotic — and more than 2.5 times the number of prescriptions for the second-most prescribed atypical antipsychotic, Abilify, and nearly four times the number for Risperdal, according to information obtained by Military Times under a Freedom of Information Act request.

In 2003, Military Times reports, service members were diagnosed with insomnia at a rate of 30 per 10,000. By 2009, the rate had jumped to 226 per 10,000. Prescriptions for Seroquel rose 27-fold in the same time period. And according to The Associated Press, in 2009, the Pentagon spent $8.6 million on the drug, while the Veterans Affairs Department spent $125.4 million. That same year, results of a proof-of-concept study showed Seroquel benefited patients with post-traumatic stress disorder (see this and this).

Meanwhile, a 2008 study in the British Journal of Clinical Pharmacology showed patients taking more than one drug that can cause irregular heartbeats had 4.8 times the risk of cardiac arrest (look here). A study the following year in The New England Journal of Medicine found the rate of sudden cardiac death doubled for those taking atypical antipsychotics, and there were three such deaths each year for every 1,000 patients taking such a drug (here is the abstract). The risk of a fatal heart event also increased with dosage, the Military Times notes.

Why Are These Fraudulent Papers Unretracted?

by MARTHA ROSENBERG

"According to Science Times[1], the Tuesday science section in the New York Times, scientific retractions are on the rise because of a “dysfunctional scientific climate” that has created a “winner-take-all game with perverse incentives that lead scientists to cut corners and, in some cases, commit acts of misconduct.”

But elsewhere, audacious, falsified research stands unretracted–including the work of authors who actually went to prison for fraud!

Richard Borison, MD, former psychiatry chief at the Augusta Veterans Affairs medical center and Medical College of Georgia, was sentenced to 15 years in prison for a $10 million clinical trial fraud[2] but his 1996 US Seroquel® Study Group research is unretracted.[3] In fact, it is cited in 173 works and medical textbooks, misleading future medical professionals.[4]

Scott Reuben, MD, the “Bernie Madoff” of medicine who published research on clinical trials that never existed, was sentenced to six months in prison in 2010.[5] But his “research” on popular pain killers like Celebrex and Lyrica is unretracted.[6] If going to prison for research fraud is not enough reason for retraction, what is?

Wayne MacFadden, MD, resigned as US medical director for Seroquel in 2006, after sexual affairs with two coworker women researchers surfaced[7], but the related work is unretracted and was even part of Seroquel’s FDA approval package for bipolar disorder.[8]"

"While the company would not comment about his retirement package, which is still being finalised, Brennan could walk away with about £5m – after receiving more than £9m in pay, perks and shares last year.

Shares in the group, which also announced a 38% drop in three-month profits to £1.34bn and a reduction in its 2012 earnings target, were the biggest fallers in the FTSE 100, down 6.1% at £26.66, wiping £2.2bn from the company's market value.

Brennan will be replaced temporarily by finance director Simon Lowth from 1 June. Former Volvo boss Leif Johansson will take over as chairman from Louis Schweitzer, 69, on the same day – three months earlier than planned. Johansson will then lead the hunt for a permanent successor to Brennan. Headhunters Spencer Stuart have been hired to scout out internal and external candidates.

Brennan, 58, said he had been contemplating his departure for some time and told the board formally of his intention to quit on Wednesday, following private conversations with the chairman. The board then decided to accelerate the process by appointing Lowth as interim CEO, a move backed by Brennan.

Both Brennan and Schweitzer were reportedly encouraged to retire earlier than planned by non-executive directors on the board. However, Brennan insisted: "The decision to retire was entirely my decision. I've been contemplating it for a while. It was time to give someone else the chance to take the company to the next level."

He said he wanted to spend more time with his family (he is married with four grown-up children and has six grandchildren) and to "figure out ways to influence healthcare from a different position"."

Tuesday, March 27, 2012

As countless injured Seroquel litigants are now being pushing & dumped into the streets by unscrupulous ambulance chaser law firms (many of those will cont. to suffer on in abject poverty without ever seeing the slightest shred of justice unto their death); And even after those DOJ (Department of Justice) fines, the massive health damage inflicted upon the general public, the ever growing volumes of documented corp crimes: AstraZeneca Chief David Brennan sees pay jump to £9.1m.

That's right folks, in that other select members only (TO BIG TO HOLD ACCOUNTABLE) world of corporate crime, pay offs, political wrangling, billion dollar legal teams, and the untold billions in ill gotten profits... CRIME PAYS....& it PAYS OFF BIG TIME

AstraZeneca chief David Brennan sees pay jump to £9.1m

AstraZeneca chief executive David Brennan saw his total pay climb to more than £9.1m in 2011, after an increased payout from a share award which vested last year.

Mr Brennan's 2008 share award also vested last year, with a value of £5.8m, the annual report shows.Photo: PA

Telegraph staff

10:20AM BST 27 Mar 2012

The pay hike happened despite concern about Astra's pipeline of new drugs, as it faces a looming "patent cliff", with several of its best-selling medicines losing exclusivity and facing competition from cheaper generic versions in the next few years.

Last week, the company had to pull the plug on an anti-depressant it was developing, incurring a $50m (£31.3m) charge, and in February announced 7,000 job cuts to save money.

Mr Brennan's base pay rose 2.5pc to £997,223 in 2011, and including a bonus and other payments, was up 11pc to £3.37m, according to the pharma company's annual report.

His 2008 share award also vested last year, with a value of £5.8m, the annual report shows.

The size of the share award was increased by 25pc by the board, after Astra came top of its peer group between 2008 and 2010.

Mr Brennan turned down any increase in his base pay for 2012, the report shows.

Well, we all knew this was coming....we just didn't know exactly how The Miller Firm LLC was going to try justifying their constant lies and magical settlement approval % manipulation. Today I received a copy of this letter below along with some enlightening correspondence from a long time trusted source.

My source stated that this "DUMP" letter is packed with misrepresentation & outright lies that have been conjured up by The Miller Firm LLC to avoid the appearance and undeniable reality that they have or are in the active process of a targeted and purposeful client dump in an unethical scheme to force a rejected settlement through solely for self gain.

My source went on to pin point inaccuracies in this DUMP letter starting with deceiving legal speak in the opening sentence stating:

My "source" unequivocally states that Saiontz & Kirk P.A. was not hired to investigate a claim, but to represent the "source" in a valid, evidenced, and documented case against AstraZeneca.

The "source" stated that they did not hire The Miller Firm LLC to represent them in any way, shape, or form. In fact, Saiontz & Kirk P.A. sold the "sources" case to The Miller Firm LLC, while having no active involvement or participation as Co-counsel in the Seroquel Litigation from that time on. In fact all client questions & inquires were automatically forwarded to The Miller Firm LLC without their response once the sale had occurred.

Now, onto the most important point and evidential lie in this "DUMP" letter. My source stated that they "NEVER" "EVER" requested that their case be closed. In fact they sent in a valid appeal letter outlining their concerns within the 7 day time limit constraints The Miller Firm LLC & the Garretson Resolution Group placed on appeals, and for signing onto or not signing onto the settlement process.

That appeal letter was completely ignored by The Miller Firm LLC. In fact on numerous occasions in direct correspondence with The Miller Firm LLC; The Miller Firm Representatives stated that they were not going to take a single case to court, none were worthy of trial, and there would be absolutely no renegotiation of the settlement terms with AstraZeneca.

The Miller Firm LLC is acting today & as were they then; they are the sole cause or catalyst behind any and all separation of legal representation. For The Miller Firm LLC to even imply that the "Source" requested that their case be closed constitutes a totally fraudulent statement and most egregious blatant lie.

Who shall you the reader believe? Let's just match & compare the signatures on the "DUMP" letter below, to the THREAT letter Mr. Miller denied he wrote to Reuters News and Insight. In fact Miller & his firm, (including co-counsel) all appear to have some serious problems related to telling the truth and subsequent honesty.

So why might you think a request for being relieved of contractual obligation or being DUMPED directly by the Miller Firm LLC makes such a huge difference in this settlement going forward?

Because The Miller Firm appears to using this misinformation/lies to drop clients from equations which directly skews the settlement acceptance percentages for this pay out proposal.

So instead of having a 40% rejection rate or 249 client rejections. The Miller Firm appears to have jettisoned most of those clients, and then went about the nasty business of recalculating the approval percentage numbers with the approximately 374 remaining approval clients to reach that magical 93% approval threshold to submit to AstraZeneca to cash in on their pay day.

The only problem here is that the clients didn't ask for their cases to be closed...they simply wanted to be properly represented or sent a notice of being released because they rejected the settlement by their original counsel. The Miller Firm is playing unethical slight of hand here...and are clearly attempting to erase the voices & rights of those injured parties that rejected this insulting settlement by closing their cases and then acting like they never existed to the calculations, the courts and to AstraZeneca... That is about as sleazy, disingenuous, and underhanded as it gets folks...

This is the 7.4 million dollar question that must be answered? Has The Miller Firm LLC & Co-counsel conspired against one segment of clients they have a sworn legal & ethical obligation too represent; to unequally represent another segment of clients they represent, solely for their own self gain & personal business interest?

This is the heart felt message I am sending out to the DOJ "Department Of Justice" & Federal Courts; are you listening to the actual injured parties and clients yet.....please do!

Monday, March 19, 2012

Hear Ye! Hear Ye! for all those injured or killed by Seroquel! it's settled Suckers

THE FIX IS IN - The Miller Firm LLC says they have magically reached settlement threshold, & are presenting results to AstraZeneca in an attempt to cash in on the Seroquel Litigation

In the continuing saga of "How the Seroquel Settlement World Turns" The Miller Firm Seroquel Update Recording today (*800* 882 -2525) announced they have reached the required number of settlement packets to move forward with asking AstraZeneca to release funds.

Of course The Miller Firm does not say how many settlement approval packets they have actually received, or how many clients they have dumped to the streets in pursuing this magical threshold mark of 93% approval.

This is all very secretive stuff that The Miller isn't sharing with their Clients or anyone else except AZ (you know the clients, injured parties, those people they are supposedly working for). Though one must seriously & reasonably wonder out loud what's really going on here; especially when a firm has been sitting at a 40% rejection rate for a year, and then in three weeks time somehow pulls a settlement agreement rabbit out of thier hat so to speak.

This is why interested parties and clients are asking & calling for an investigation by Federal authorities @ the Department of Justice and the Court. Not only does the documented actions of The Miller Firm not passing the ethical & professional smell test....shall we start throwing around nasty words like "Fraud"? "Racketeering"? "Conspiracy"? or other related pleasantries to garner attention to the Injured Parties plight....The time has now come to have this secretive & unsavory curtain pulled back for all to see...

We know that The Miller Firm LLC and non-participant co-counsel have been tooting the settlement horn with their cheerleader buddies at the Garretson Resolution Group & AstraZeneca for over a year now. From the clients I've had correspondence with...The Miller Firm has quashed any & all conversation, inquiry, or mention of further negotiations or any chance of preparing their cases further for trial.

There are so many questions, yet The Miller Firm & co-counsel refuse to answer any and all questions that don't directly refer to getting this settlement approved, or getting that settlement cash in their pockets.

This blog has chronicled this secretive, often threatening, and closed door process for almost a year now....Injured parties that are refusing this insulting & unfair offer are no closer to receiving legitimate counsel, a court hearing before a jury of their peers, or finding even the most remote form of justice now, anymore than they were then.

This is a testament to how truly perverted and corrupted our legal system, the law profession, and the courts have become. It seems or appears that only the wealthy, elite, politically connected, corrupted, and those recognized into the small members only club receive the treasured promise of the courts and justice in America...The rest receive what has been written on the pages of this blog....it's simply insult added to injury....

I invite you the reader to go back & read through this blog's journey over the past many mouths & ask yourself this question; Have injured parties in the Seroquel litigation received anything that can be taken as, would be construed as, or closely resembling justice from the courts, media, their own legal representation, and most of all....from the AstraZeneca corporation that with forethought and malice caused them grave injury or death with the drug Seroquel?

as they say....this ain't over until the last Seroquel induced fat lady sings....

But then again...will injured parties even be dealing with AstraZeneca six months or a year down the road...or some other huge corporate entity?-----------------------------------------

Despite a brimming pipeline touted by execs earlier this year, storm clouds are gathering for AstraZeneca, and the best way to weather them is through a takeover, says one analyst.
If it wants to deliver results, the UK drugmaker's dwindling set of options really boils down to one: take over a company with a pipeline that will keep it afloat, wrote Tim Anderson of Sanford Bernstein.

In a note titled, "Something's Gotta Give. But When & Why?" Anderson writes of a "left for dead" attitude by many investors towards the company. “AZN faces a prolonged, multi-year patent cliff that gives it among the steepest revenue and EPS declines of the different US and European companies we cover,” Anderson noted, referring to a slew of patent expirations that start in 2012 and run through the next the next four years. Among those aging out this year are anti-psychotic Seroquel and blood pressure drug Atacand. Seroquel IR and XR brought in over $6 billion in sales for the company last year, and Atacand brought in almost $2 billion. Blockbuster Crestor ($6.6 billion in sales last year), already generic in some European markets and facing a threat from off-patent Lipitor in the US, is scheduled to lose US exclusivity in 2016.

Saturday, March 17, 2012

AstraZeneca Sues the FDA to extend Seroquel patent & profits - The outrageous hypocrisy of it all

Yes, it's beyond ludicrous I know....but those very same greed mongering corporate thugs @ AstraZeneca who have stolen literally mountains of money by their blatant acts of illegal marketing, political pandering & deceit, and by hiding the dangerous & deadly side effects of the drug Seroquel while making it a multi-billion dollar a year block buster; are now suing the FDA because the soon to be released generic version of Seroquel doesn't have the exact same label warning incert as the AstraZeneca patented version.

Now, very few rational people are going to argue that full, safe, and complete product labeling isn't a good thing. But let's get real here....AstraZeneca has never been concerned about safety or patient health when it comes to Seroquel...they sure as hell didn't want consumers (or anyone else for that matter) knowing all the dirty secrets and dangerous details of this drug when marketing Seroquel into a mega billion dollar per year profit maker. Now they want to hold on to their deadly cash cow patent even longer...please give us all a break...this is yet another case of the special & privileged corporate elite abusing the legal system, the citizens of America, & others from around the world purely for greed's sake.

AZ's Seroquel Battle with FDA: A Mark of Desperation?

Is it a mark of desperation? UK-based pharma company AstraZeneca has resorted to suing the US Food and Drug Administration in a bid to stop it from approving generic competition to Seroquel, the company’s blockbuster anti-depressant, before December 2012. The core patent for Seroquel IR expired in September last year, and its paediatric patent runs out this month, although Seroquel XR (the later version) still has protection till 2017.

The FDA has yet to approve a generic version, and AstraZeneca is arguing that it should not do so. The company claims that important decisions have still not been made over warning labels on the generic versions of Seroquel IR, which need to mimic those on the original, while it still has data exclusivity rights stemming from the clinical trials it has conducted.

AstraZeneca tried a Citizens’ Petition against the FDA earlier this month, with no joy, so it is now trying a lawsuit. The case is a long shot, but the costs will certainly be far lower than the losses the company will incur when Seroquel’s patent expires. The drug generated sales of US$4.3bn worldwide last year, of which US$3.3bn was in the US. Moreover, if AstraZeneca wins, then it (and other companies) may also have developed another way of extending protection for many of the drugs that are coming off-patent.

If so, that would be very welcome news in this, the steepest year of the patent cliff. This year, around US$27bn-worth of blockbuster sales will be exposed to generic competition in the US, according to Fitch Ratings. AZ, along with Pfizer and Forest Laboratories of the US, is one of the companies hardest hit. AZ calculates that it lost almost US$2bn in revenue during 2011 as a result of generic competition. Other companies have tried different tactics to protect their patents – Pfizer, for example, struck exclusivity deals with pharmacy benefits managers to protect sales of Lipitor after its US patent expired late last year.

Yet the mood in the US is firmly against pharma companies who are seen as blocking competition, making the likelihood of AZ winning its case appear remote. Though attempts to legislate have foundered, the current US government has campaigned against what it dubs “pay-for-delay” tactics, which mainly involve deals between pharma companies and their potential generic competitors. The chairman of the Federal Trade Council Jon Leibowitz claimed last year that such arrangements cost consumer US$3.5bn a year in higher drug prices.

---------------------------------------------

Once again in this article above, Seroquel is being referred to as an antidepressant drug - so let's make it absolutely clear, and correct once again this often used blatant mistake reported by the main stream media & others.

Seroquel is not an antidepressant drug...it is a powerful neuroleptic drug (anti-psychotic).

neuroleptic drug - tranquilizer used to treat psychotic conditions when a calming effect is desired

Glenn Armstrong, 19, of 1702 Railroad Ave., Monroe, was booked into Ouachita Correctional Center on charges of possession of Seroquel, possession of marijuana, possession of controlled and dangerous substances in the presence of juveniles, stop sign violation, no driver's license and no insurance.

An arrest affidavit stated an officer was traveling westbound on Texas Avenue when he saw the driver of a Mazda vehicle run a red traffic light at the intersection with South Second Street. Police said the driver, later identified as Armstrong, stopped in the 500 block of South First Street.During the traffic stop, police said Armstrong could not show them a proper driver's license or proof of insurance. Police said Armstrong appeared to be nervous.

The report stated police saw two 16-year-old juveniles in Armstrong's vehicle. A search of the vehicle revealed a bottle of suspected Seroquel pills and a small bag of suspected marijuana. The unnamed juveniles told police Armstrong had been trying to sell the suspected pills before he was stopped.

Pennsylvania has investigated and removed some doctors who were among the top prescribers of painkillers and mental health drugs for Medicaid patients, officials said in a letter made public on Friday.

Five doctors were disqualified from participating in the program; four had their licenses suspended; two were referred to prosecutors for review; and one is under investigation, the state Department of Public Welfare told U.S. Senate investigators.

The state reported its actions in a Feb. 27 letter to Sen. Charles Grassley, R-Iowa, who has been investigating abuses nationwide of medicines such as the anti-depressant Xanax. Pennsylvania initially provided information about the top 10 prescribers of eight antipsychotic, painkiller or anti-anxiety drugs to Grassley in 2010.

"We are seeing that certain states, including Pennsylvania, are reporting that they or the state medical board has taken action against medical providers, and that's good news," said Jill Gerber, Grassley's spokeswoman.

The state welfare department said it sent intervention letters to 51 other doctors, showing their patients' drug histories. The state said its program encourages doctors to discontinue unnecessary prescriptions, reduce drug quantities or switch to other treatments.State officials declined to identify any doctors.

"Our administration is dedicated to rooting out all waste, abuse and fraud in our programs and services," spokeswoman Donna Kirker Morgan said in a statement.

"Although the senator's questions are an interesting snapshot of antipsychotic drug utilization in the Medicaid system, the questions do not delve into important facts and backgrounds about patients and their current needs for such drugs and the circumstances for such prescriptions."

Top prescribers continue to dispense many of the drugs at a high cost for taxpayers, the state's response shows. Along with its letter, public welfare reported the top 10 prescribers for eight drugs, showing the number of prescriptions each doctor wrote and the dollar value of them.
One doctor last year gave out 6,950 prescriptions for Xanax — or more than 19 every day — at a cost of nearly $70,500. The year before, another doctor wrote 1,864 prescriptions for Seroquel, an antidepression and schizophrenia drug that can cost up to $12 per tablet. The Seroquel prescriptions cost taxpayers more than $1 million.

The state attorney general's office could not immediately provide details about whether any of the public welfare referrals resulted in prosecution. "We aggressively pursue provider fraud, which diverts limited taxpayer resources from Medicaid recipients with legitimate needs," spokesman Nils Hagen-Frederiksen said.

The state's response to Grassley was made public yesterday when the agency responded to a Right-to-Know Request filed by Ken Kramer, an investigator for Citizens Commission on Human Rights International, a group that investigates and exposes psychiatric abuse.

"It's very good to see Pennsylvania taking action," Kramer, 55, of Clearwater, Fla., said in an email to the Tribune-Review. "There is no debate on this: Patients are overdrugged, Medicaid is overbilled and taxpayers are overburdened -- all caused by the bogus prescribing of psychiatrists."

Where we left off in the last Post HERE , The Miller Firm LLC was reporting they had magically reached 78% acceptance figure for the Seroquel settlement offer; even though for many months there has been a 40% rejection of the same settlement offer. This week on The Miller Firm Seroquel Update Recording (*800* 882 -2525) states that they have now reached an 85% approval; while going further to boast & state that they will meet their goal this week ( 93% approval is needed for the settlement to go forward) .

WOW!! How does something like this happen? Shall we start wondering how one goes (in a couple of weeks) from a settlement that was dead and buried to a miraculous acceptance of 93%?

1. We know these firms have been marketing the heck out of this lousy settlement for almost a year now..

2. We also know The Miller Firm had/has made in quite clear to anyone appealing the process or who has not signed onto this settlement would be dropped from representation (evidenced by The Miller Firms numerous statements that there would be absolutely no re-negotiations, that client appeals would & have been ignored, & there would zero trials going forward).

3. We also know the stated settlement deadlines have come & gone....then out of thin air are being extended only to suite the law firms whimsical insistence that this settlement be accepted for their own selfish gain...(not acting in the clients best interest)

OK, we know that the above statements has been the sleazy case & hard to stomach reality for some time now....so what else has magically changed in the past couple of weeks?

4. How about the dumping of clients! it sure appears that The Miller Firm has conspired against & jettisoned clients that did not accept the settlement, & are holding back that information/notification until they get the settlement money in their grubby and greedy legal mitts; and are recalculating (or are now in the process of recalculating) the new numbers to meet the 93% acceptance threshold criteria for AstraZeneca to release settlement funds. It's not like it's any hidden secret at this juncture that The Miller Firm & their Sleazy "gather & sell clients" co-counsel are in this for the money & very little else.....

Now if that is what has actually happened; then not only is it not kosher or ethical; It also flies in the face of any reasonable or rational comprehension of the original settlement offer which was supposedly sent out to all the 623 clients The Miller Firm were supposedly representing.

Radical changes in events and the status of tort settlements don't just change like this overnight....There must be explanations, extenuating factors or justifiable reasons behind such changes....I believe clients have a right to know....after all....who is The Miller Firm & their co-counsel legally and ethically bound to represent in their best interest....the clients or just themselves?

Of course The Miller Firm as usual is being very secretive, tight lipped, and closed mouth about what they are doing...They will only make references or comments related to pushing this offer through at all cost & nothing else.

In fact, anyone questioning the process or this settlement approval push is ostracized from not only the entire process, but from all pertinent information & inquiry (including receiving mailings and letters that were supposedly sent out to all represented clients!!).

Considering The Miller Firms track record and history of supplying misleading/misinformation/bullshit(lies) throughout this whole ordeal; I & others are calling for the court and federal authorities to investigation the practices and actions that have been used and employed by The Miller Firm and related co-counsel throughout this litigation. Something smells completely rotten here; injured clients & the public have a right to know what's really going on!

It’s appears The Miller Firm (including client gathering and case selling non-participant co-counsel Saiontz & Kirk, P.A , Ennis&Ennis, P.A. ) are in a desperate “sell the failed settlement” at all cost mode presently. Just three weeks ago The Miller Firm had stated in their update phone recording that they only had somewhere around 60% of the 93% settlement acceptance needed for the Seroquel settlement to fly. This past week after a concerted “Sell the Settlement” campaign they are now claiming a 78% acceptance figure; while also claiming that they have mailed out a “letter” to all their Seroquel Clients.

The Miller Firm seems to say a lot of things…yet how much of it is truth, and how much of it is just meaningless bravado & blatant lies?

Let's look at this example from The Miller Firm web site:

I & others can attest that this statement & claim is complete bullshit, & one utter laughable falsehood.

I happen to personally stay in contact with some of The Miller Firm clients. One of sources stated The Miller Firm had told them three weeks ago that they were being dropped as a client for not accepting the settlement offer & would receive a letter stating that fact within seven days; That letter has never arrived! This same client also has not received this latest “sell the settlement” propaganda letter The Miller Firm has claimed to have sent out to “all” of their clients.

It is truly a nasty & underhanded business for ambulance chaser firms like “Miller” who are attempting to sell a horrible & unfair settlement offer for AstraZeneca & themselves, while throwing actual injured parties under the bus.

In fact, it’s actually quite difficult to differentiate who is worse or more evil in this litigation: AstraZeneca whose product Seroquel has purposely harmed & killed so many to make Money, or the plaintiff law firms that are using their Seroquel clients simply as cash cows to collect large windfall paydays for themselves.

There’s only one thing we know for sure & as absolute truth: Seroquel injured parties are not receiving proper representation or anything that can be construed as being within the realm of actual justice. This whole litigation amounts to nothing more than shady backrooms and a very secretive member’s only club of greedy & self serving individuals/law firms that are shaking down those forever injured Seroquel clients for their own personal profit & gain.

The numbers don't lie:

So how does The Miller Firm offer stack up against other settlement offers in this litigation?: SAME COURT, SAME DRUG, SAME INJURIES -

(Please note this settlement is not & has never been about injuries suffered by claimants, or holding AstraZeneca accountable for their despicable actions : it is only about the cost of continuing to litigate claims. The Plaintiff law firms have created out of thin air a false & misleading perception that this settlement offer is about receiving compensation for injuries incurred! IT IS NOT! That is a disingenuous ploy & misrepresentation of reality being used to sell this settlement and for nothing else)

Now let us look at the numbers in The Miller Firm settlement offer that they are so desperately selling their clients at present: (ask yourself who is winning and who is losing here?)

Total Settlement Offer is roughly7.4 million dollars (including hold back funds).

The Miller Firm & their Co-counsel are taking 40% plus fees & expenses right off the top: a ballpark figure of a 2.7 million dollar pay day(not bad for not preparing or having cases ready for trial.....just sitting around in some backroom swinging a sweet deal for themselves)

Then the Garretson Resolution Group is calculated into the racket for their piece of the action: (they do the paper work, create the "sell the settlement" packets, and barter lean resolution for a nice slice of pie somewhere in the neighborhood of $260,000 dollars

Then Uncle Sam steps in & takes their % cut for Medicare/Medicaid reimbursement; plus there are other potential private leans or outstanding debts that can be deducted...this amount will vary for each client/state/&situation.

Then at the very tail end of the settlement feast; the injured party receives their actual paltry offer; which averages in the neighborhood of 4 to 5 thousand dollars.

So as you can see: everyone has their hands in the settlement cookie jar, except the actual injured parties. The lawyers get rich and move on to their next drug or device litigation for another backroom golden deal. All the tag a longs like Garretson grab their share.

And probably the greatest injustice of all is that AstraZeneca clears the slate; paying out virtually nothing to forever cover their criminal actions and the damage Seroquel has directly caused (& will continue to cause) to many thousands of innocent citizens; while AZ has made & will continue making untold billions of dollars in pure profit.

AstraZeneca today announced that on 7 March 2012, the FDA denied Citizen Petitions requesting that the FDA withhold finally approving any generic quetiapine product with labelling that omits certain hyperglycaemia warning language that the FDA required AstraZeneca to include in the labelling for SEROQUEL® (quetiapine fumarate) and SEROQUEL XR® (quetiapine fumarate).

The U.S. FDA acts with reckless endangerment when it omits ANY drug side effect warnings from the label of the antipsychotic Seroquel (quetiapine). The antipsychotic is being prescribed for off-label use for insomnia, anxiety, for PTSD, to war veterans, to children--and the FDA which could act as a gatekeeper for drug safety---continues to promote the use of this dangerous product by actions like this. The fact that the drug made its way to the market place with a background of buried data and internal documents that show AstraZeneca's intent to market the drug anyway should be enough to pull this drug from sales. Instead it receives numerous and seemingly endless indications and now is on its way to generic version. The off-label prescribing will only increase with that version available!

AstraZeneca's Citizen Petition appears to be one of serving the public, but make no mistake that was a move to keep this drug non-generic as long as possible for $$$ The major drug company with over 26,000 lawsuits for diabetes (which still is being ironed out, as the plaintiffs have not received settlements yet) suddenly wants to display all hyperglycemia related labeling on generics?

Why didn't AstraZeneca display that on the product label from the beginning? The company buried Study 15, skewed data and KNEW the drug could cause weight gain and diabetes! NOW they want to be treated equally? If the generic drug doesn't have all the warning labels we were required to have then let's complain to the FDA? I smell $$$$$$$!

In the December 2010 issue, Hollingworth et al. (2010) detailed increased prescribing of atypical antipsychotic medications in Australia between 2002 and 2007. While olanzapine and risperidone remain the most commonly prescribed atypical antipsychotics, quetiapine prescribing is increasing, with PBS prescriptions rising by 27% between 2008/09 (431,096) and 2009/10 (545,410) (Department of Health and Ageing, 2010). Reasons for the growing use (including off-label prescribing) relate to its sedative properties and favourable extrapyramidal and metabolic profile, as well as emerging evidence of positive outcomes at low doses for a range of mental disorders (Hollingworth et al., 2010).

While the toxicity profile of atypical antipsychotics is considered preferable to typical agents, particularly regarding overdose risk, recent literature has called the relative safety of quetiapine into question. In one study, quetiapine-related overdoses were more likely to result in hypotension, respiratory depression, coma, or death than all the other antipsychotics combined (Ngo et al., 2008). This is particularly concerning given the growing number of case reports citing quetiapine as a potential substance of misuse, a phenomenon unseen with other atypical antipsychotic preparations (Sansone and Sansone, 2010).

A recent study (Lloyd and McElwee, 2011) identified a non-significant increase in antipsychotic-related ambulance attendances over 2000−2009 in metropolitan Melbourne. While demographic characteristics remained relatively consistent over the period, there was a significant increase in antipsychotic-related attendances where other drugs (both licit and illicit) were also implicated in presentations. However, differential harms across different antipsychotic preparations have not been adequately explored at a community level.

To further our understanding of this emerging issue, we analysed ambulance attendance data from metropolitan Melbourne across different antipsychotic preparations to provide a preliminary quantification of quetiapine-related harms. Data were derived from the Ambo Project database (Lloyd and McElwee, 2011), utilizing data from patient care records completed by paramedics, with additional coding undertaken to identify involvement of alcohol or other drugs in ambulance presentations. While there was a small increase in antipsychotic-related ambulance attendances between 2000/01 and 2009/10 (from 783 to 1074 attendances), quetiapine-related attendances increased substantially over the same period (from 32 in 2000/01 to 598 in 2009/10). Similar increases were not found for other antipsychotic preparations.

Anecdotal reports from Victorian alcohol and drug agencies participating in the Earlier Identification of Drug Harms Project (unpublished data) indicate that quetiapine demand, use, diversion, misuse, and harms are ongoing issues, particularly for clients with a history of illicit drug use. Over the course of this project involving bi-monthly data collection, quetiapine was the only antipsychotic consistently reported as being used in a problematic manner, regardless of source of supply.

Such an increase in acute quetiapine-related harm represents a growing public health issue. Further exploration is required to identify the nature and magnitude of quetiapine-related harms, population groups at increased risk of harm, prescribing trends, and strategies to ensure benefits of quetiapine are balanced against potential risks to patients, and costs to the community. In the meantime, it is important that clinicians are aware of growing misuse and diversion of quetiapine, and adopt prescribing practices that minimize the risk of harms.

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Miller Firm LLC gets $6 million from AstraZeneca

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This blog is a place where all victims of Seroquel can fight for reasonable justice. I would encourage you (The victims, or family members, or loved ones of victims) to becomes involved and make your voice heard. You can submit articles, information, letters, news, stories, and suggestions through email @ seroquellawsuitblog@gmail.com

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